The Food and Drug Administration says it has received seven reports of serious health problem among people who used the product, including vomiting, diarrhea and kidney malfunction. The agency also says it has received information showing that samples of Soladek contain unsafe levels of vitamins A and D.

Soladek is marketed by Indo Pharma, a company based in the Dominican Republic. The solution comes in a vial and is labeled in Spanish.

The FDA said the product violates U.S. law because it claims to treat various medical conditions, including rickets and infection, but has not undergone regulatory review.